<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00889989050462</udiDi>
    <basicUdiDi>B-00889989050462</basicUdiDi>
    <tradeName>L4L TWIN DB/UL 22 ANDREWS T2 PA 5/-17/4</tradeName>
    <deviceName>L4L TWIN DB/UL 22 ANDREWS T2 PA 5/-17/4</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1049</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:14.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050455</udiDi>
    <basicUdiDi>B-00889989050455</basicUdiDi>
    <tradeName>L4L TWIN DB/UL 22 ROTH DBHK -1/-17/4</tradeName>
    <deviceName>L4L TWIN DB/UL 22 ROTH DBHK -1/-17/4</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1047</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:13.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050448</udiDi>
    <basicUdiDi>B-00889989050448</basicUdiDi>
    <tradeName>L4L TWIN DB/UL 22 ANDREWS BHK 2/-17</tradeName>
    <deviceName>L4L TWIN DB/UL 22 ANDREWS BHK 2/-17</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1046</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:12.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050431</udiDi>
    <basicUdiDi>B-00889989050431</basicUdiDi>
    <tradeName>L4L TWIN DB/UL 22 ROTH HK -1/-17/4</tradeName>
    <deviceName>L4L TWIN DB/UL 22 ROTH HK -1/-17/4</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1045</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:09.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050424</udiDi>
    <basicUdiDi>B-00889989050424</basicUdiDi>
    <tradeName>L4L TWIN DB/UL 22 ROTH NHK -1/-17/4</tradeName>
    <deviceName>L4L TWIN DB/UL 22 ROTH NHK -1/-17/4</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1044</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:08.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050417</udiDi>
    <basicUdiDi>B-00889989050417</basicUdiDi>
    <tradeName>L4L TWIN DB/UL 22 ANDREWS 2/-17</tradeName>
    <deviceName>L4L TWIN DB/UL 22 ANDREWS 2/-17</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1041</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:07.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050400</udiDi>
    <basicUdiDi>B-00889989050400</basicUdiDi>
    <tradeName>L5L TWIN DB/UL 22 ANDREWS DBHK OF/GV 2/-22</tradeName>
    <deviceName>L5L TWIN DB/UL 22 ANDREWS DBHK OF/GV 2/-22</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1039</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:05.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050394</udiDi>
    <basicUdiDi>B-00889989050394</basicUdiDi>
    <tradeName>L5L TWIN DB/UL 22 ANDREWS OF/GV 2/-22</tradeName>
    <deviceName>L5L TWIN DB/UL 22 ANDREWS OF/GV 2/-22</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1038</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:03.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050387</udiDi>
    <basicUdiDi>B-00889989050387</basicUdiDi>
    <tradeName>L5L TWIN DB/UL 22 ANDREWS T3 PA -2/-22/6</tradeName>
    <deviceName>L5L TWIN DB/UL 22 ANDREWS T3 PA -2/-22/6</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1037</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:01.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050370</udiDi>
    <basicUdiDi>B-00889989050370</basicUdiDi>
    <tradeName>L5L TWIN DB/UL 22 ANDREWS T2 PA -1/-22/4</tradeName>
    <deviceName>L5L TWIN DB/UL 22 ANDREWS T2 PA -1/-22/4</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1036</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:30:00.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050363</udiDi>
    <basicUdiDi>B-00889989050363</basicUdiDi>
    <tradeName>L5L TWIN DB/UL 22 ANDREWS T1 PA 0/-22/2</tradeName>
    <deviceName>L5L TWIN DB/UL 22 ANDREWS T1 PA 0/-22/2</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:59.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050356</udiDi>
    <basicUdiDi>B-00889989050356</basicUdiDi>
    <tradeName>L5L TWIN DB/UL 22 ROTH BHK -1/-22/4</tradeName>
    <deviceName>L5L TWIN DB/UL 22 ROTH BHK -1/-22/4</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1034</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:56.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050349</udiDi>
    <basicUdiDi>B-00889989050349</basicUdiDi>
    <tradeName>L5L TWIN DB/UL 22 ANDREWS DBHK 2/-22</tradeName>
    <deviceName>L5L TWIN DB/UL 22 ANDREWS DBHK 2/-22</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1033</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:55.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050332</udiDi>
    <basicUdiDi>B-00889989050332</basicUdiDi>
    <tradeName>L5L TWIN DB/UL 22 ROTH N/HK -1/-22/4</tradeName>
    <deviceName>L5L TWIN DB/UL 22 ROTH N/HK -1/-22/4</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1031</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:54.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050325</udiDi>
    <basicUdiDi>B-00889989050325</basicUdiDi>
    <tradeName>L5L TWIN DB/UL 22 ANDREWS 2/-22</tradeName>
    <deviceName>L5L TWIN DB/UL 22 ANDREWS 2/-22</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:52.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050318</udiDi>
    <basicUdiDi>B-00889989050318</basicUdiDi>
    <tradeName>U4&amp;5L TWIN DB/UL 22 ANDREWS OF/GV 2/-7</tradeName>
    <deviceName>U4&amp;5L TWIN DB/UL 22 ANDREWS OF/GV 2/-7</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1026</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:50.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050301</udiDi>
    <basicUdiDi>B-00889989050301</basicUdiDi>
    <tradeName>U5L TWIN DB/UL 22 ANDREWS T3 PA -2/-7/6</tradeName>
    <deviceName>U5L TWIN DB/UL 22 ANDREWS T3 PA -2/-7/6</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:48.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050295</udiDi>
    <basicUdiDi>B-00889989050295</basicUdiDi>
    <tradeName>U4&amp;5L TWIN DB/UL 22 ANDREWS BHK 2/-7</tradeName>
    <deviceName>U4&amp;5L TWIN DB/UL 22 ANDREWS BHK 2/-7</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1024</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:48.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050288</udiDi>
    <basicUdiDi>B-00889989050288</basicUdiDi>
    <tradeName>U4&amp;5L TWIN DB/UL 22 ANDREWS 2/-7</tradeName>
    <deviceName>U4&amp;5L TWIN DB/UL 22 ANDREWS 2/-7</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:46.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989050271</udiDi>
    <basicUdiDi>B-00889989050271</basicUdiDi>
    <tradeName>U4L TWIN DB/UL 22 ANDREWS T2 PA 5/-7/4</tradeName>
    <deviceName>U4L TWIN DB/UL 22 ANDREWS T2 PA 5/-7/4</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>464-1017</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:29:44.008Z</lastUpdated>
  </row>
</eudamedExport>